GOOD NEIGHBOR PHARMACY EYE ITCH RELIEF- ketotifen fumarate solution

good neighbor pharmacy eye itch relief by

Drug Labeling and Warnings

good neighbor pharmacy eye itch relief by is a Otc medication manufactured, distributed, or labeled by Dispensing Solutions, Inc., PSS World Medical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Use

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

Do not use

. If solution changes color or becomes cloudyi

. If you are sensitive to any ingredient in this product

. To treat contact lens related irritation

When using this product

. Do not touch tip of container to any surface to avoid contamination

. Remove contact lenses before use

. Wait at least 10 minutes before reinserting contact lenses after use

. Replace cap after each use

Stop use and ask a doctor if

you experience any of the following:

. Eye pain

. Changes in vision

. Redness of the eye

. Itching worsens or lasts for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

. Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.

. Children under 3 years of age: Consult a doctor.

Other information

. Only for use in the eye

. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]

Inactive ingredients

benzalkonium chloride 0.01%, glycerin, purified water. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions or comments?

1-800-719-9260

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

NDC: 68258-8900-05

INGREDIENTS AND APPEARANCE

GOOD NEIGHBOR PHARMACY EYE ITCH RELIEF 
ketotifen fumarate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68258-8900(NDC: 24385-494)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G)	KETOTIFEN	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68258-8900-5	5 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077958	11/13/2010

Labeler - Dispensing Solutions, Inc. (066070785)

Registrant - PSS World Medical, Inc. (101822682)

Establishment
Name	Address	ID/FEI	Business Operations
Dispensing Solutions, Inc.		066070785	relabel(68258-8900) , repack(68258-8900)